Skin QualityNCT05595525
Laser Treatment to Improve Skin Quality
A study testing 1064NM pico Laser and 755NM pico Laser in people with Skin Quality, run by Goldman, Butterwick, Fitzpatrick and Groff.
Trial summary
To assess the efficacy of a 1064nm picosecond laser (PicoWay; Candela; Marlborough, MA) with diffractive lens array and a picosecond 755nm laser (PicoSure®; Cynosure®; Westford, MA) with diffractive lens array in subjects for the improvement of facial skin quality. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Quality
- What is being tested?
- 1064NM pico Laser and 755NM pico Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult males and females aged 18 to 65 years
- Fitzpatrick skin types I-VI
- Subjects in good general health based on investigator's judgment and medical history
- Must be willing to give and sign an informed consent form and photographic release form
- Willingness to have facial exams and digital photographs performed of the face
- Physician evaluator classifying the subject as moderate or severe in all categories of the Scientific Assessment Scale of Skin Quality (SASSQ): elasticity, wrinkles, skin surface roughness, lentigines/pigmentation, erythema, blemishes, and pore size
Show all 14Show fewer
- No change in topical skin care regimen for duration of study
- Must be willing to maintain usual sun exposure
- Subject agrees to avoid tanning or use of sunless tanner during the entire course of the study
- Negative urine pregnancy test result at the time of study entry (if applicable)
- For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.
- A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
- Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active.
- Must be willing to comply with study treatments and complete the entire course of the study
Who cannot join
- Mesotherapy, dermal fillers, biostimulatory injectables, and/or fat grafting in the treatment area during the 12-month period before study treatment
- Energy-based device (i.e., radiofrequency device treatments, microfocused ultrasound device or other ultrasound-based device treatments, laser and light-based device treatments, microneedling) treatment in the treatment area in the last 6 months
- Surgery (i.e., face lift, eyebrow lift, neck lift or lower rhytidectomy, liposuction to the neck and/or submentum, etc.) during the 12-month period before study treatment
- Chemical peel or microdermabrasion of the face within 30 days prior to enrollment in the study
- Any investigational treatment for improvement of skin quality and/or photodamage of facial skin during the 12-month period before the study treatment
- Recent use of topical tretinoin, adapalene, tazarotene, hydroquinone, imiquimod, 5- fluorouracil, ingenol mebutate, concentrated hydrogen peroxide or diclofenac to the face within the previous 2 weeks
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- Creams/cosmeceuticals and/or home therapies to prevent or treat photodamage, uneven skin pigmentation, excessive erythema (redness), fine lines/wrinkles, skin laxity and/or pore size during the 4-week period before study treatment
- Subjects with scarring in the treatment areas
- Subjects with tattoos or permanent implants in the treatment areas
- Subjects with a significant history or current evidence of a medical, psychological, or other disorder that, in the investigator's opinion, would preclude enrollment into the study
- Subjects with a history of or presence of any skin condition/disease (including but not limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses, keratinocyte carcinoma, melanoma, etc.) in the treatment area that might interfere with the diagnosis or evaluation of study parameters
- Skin with open wounds, excessively sensitive skin, neurotic excoriations, dermatitis or inflammatory rosacea in the treatment area
- History of keloid or hypertrophic scarring
- Subjects with an active bacterial, viral, or fungal infection of the treatment areas
- Subjects who spray tanned or used sunless tanners in the treatment areas four (4) weeks prior to study treatment
- History of lidocaine and/or tetracaine sensitivity deemed by the investigator to preclude the subject from enrolling into the study
- Individuals with known allergies or sensitivities to any of the ingredients of any topical products being used in this study
- Subjects on systemic steroids (i.e., prednisone, dexamethasone), or topical steroids on the face which should be rigorously avoided prior to and throughout the course of treatment
- Subjects planning any cosmetic procedure to the treatment areas during the study period, other than the treatment that will be performed by the investigator
- Presence of incompletely healed wound(s) in the treatment area
- Subjects who are on an immunosuppressant or have an autoimmune condition
- Female subjects who are pregnant, planning a pregnancy, or breast feeding during the study
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Single-center, Double-blinded, Randomized, Split-face Study Evaluating 1064nm Versus 755nm Picosecond Lasers With Diffractive Lens Array for Improvement of Skin Quality
To assess the efficacy of a 1064nm picosecond laser (PicoWay; Candela; Marlborough, MA) with diffractive lens array and a picosecond 755nm laser (PicoSure®; Cynosure®; Westford, MA) with diffractive lens array in subjects for the improvement of facial skin quality. Secondary objectives of this clinical trial are to assess whether the 1064nm or 755nm picosecond laser is more efficacious in improving facial skin quality, safety of the procedure, comfortability of the procedure, and subject satisfaction.
Read the detailed description
subject will be randomized to have either their right facial half or left facial half treated with the 1064nm picosecond laser with diffractive lens array. The contralateral facial half not randomized will be treated with the 755nm picosecond laser with diffractive lens array. Subjects will receive three (3) treatments, four (4) weeks ± 7 days apart to each facial half.
For additional comfort, cold air cooling (Zimmer MedizinSystems, Irvine, CA) set on level 5 will be used throughout the treatment. After each treatment, subjects will be provided with CeraVe gentle facial cleanser (CeraVe; New York, NY) and CeraVe lotion (CeraVe; New York, NY) to be used twice daily for two weeks. Additionally, a mineral CeraVe sunscreen (CeraVe; New York, NY) will also be provided to subjects to be used every morning with reapplication every two (2) hours if going outside for the entirety of the study.
- Conditions
- Skin Quality
- Being tested
- 1064NM pico Laser, 755NM pico Laser
- Keywords
- wrinkles, fine lines, sun spots, laxity, facial laxity
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1064NM pico LaserDevice
Also called Candela 1064NM Laser
There have been small studies demonstrating the use of picosecond lasers for treatment of wrinkles and skin laxity; however, there have been no studies investigating the use of picosecond lasers for the overall improvement in skin quality.
755NM pico LaserDevice
Also called Cynosure 755NM Laser
There have been small studies demonstrating the use of picosecond lasers for treatment of wrinkles and skin laxity; however, there have been no studies investigating the use of picosecond lasers for the overall improvement in skin quality.
| Study group | Role | What they receive |
|---|---|---|
| Group A = right side face treated with 1064nm and left with 755nm | Experimental | subject will have their right half of their face treated with the 1064nm picosecond laser with diffractive lens array. Then the contralateral, left half will be treated with the 755nm picosecond laser with diffractive lens array. Subjects will receive three (3) treatments, four (4) weeks ± 7 days apart to each facial half. Receives: Device: 1064NM pico Laser; Device: 755NM pico Laser |
| Group B = left side face treated with 1064nm and right with 755nm | Experimental | subject will have their left half of their face treated with the 1064nm picosecond laser with diffractive lens array. Then the contralateral, right half will be treated with the 755nm picosecond laser with diffractive lens array. Subjects will receive three (3) treatments, four (4) weeks ± 7 days apart to each facial half. Receives: Device: 1064NM pico Laser; Device: 755NM pico Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scientific Assessment Scale of Skin Quality (SASSQ) to assess change
Scientific Assessment Scale of Skin Quality (SASSQ) (circle one)
Elasticity
0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe
Wrinkles
0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe
Skin Surface Roughness
0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe
Lentigines/ Pigmentation
0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe
Erythema
0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe
Pore Size
0- Fine 1- Small 2- Moderate 3- Large 4- Very Large
Measured: Screening, Baseline, Day 28, Day 56, Day 140
Physician Global Aesthetic Improvement Scale (PGAIS) by blinded investigator to assess change
Blinded Physician Global Aesthetic Improvement Scale Assessment (PGAIS) Rating Description
- Very Much Improved: Optimal cosmetic result in this subject.
- Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject.
- Improved: Obvious improvement in appearance from initial condition, but a re- treatment is indicated.
- No Change: The appearance is essentially the same as the original condition.
- Worse: The appearance is worse than the original condition. Scores (write a number under each treated area or check "Not Treated")
Left Facial Half Right Facial Half
Not Treated Not Treated
Measured: Day 28, Day 56, Day 140
Percent improvement of skin quality by blinded investigator to assess change
Blinded Investigator Percent Improvement Evaluation - Left Facial Half Degree of improvement from clinical evaluation, compare to baseline, using a 1-10 scale.
1 (0-10%) 2 (10-20%) 3 (20-30%) 4(30-40%) 5 (40-50%)
6 (50-60%) 7 (60-70%) 8 (70-80%) 9 (80-90%) 10 (90-100%)
Blinded Investigator Percent Improvement Evaluation - Right Facial Half Degree of improvement from clinical evaluation, compare to baseline, using a 1-10 scale.
1 (0-10%) 2 (10-20%) 3 (20-30%) 4(30-40%) 5 (40-50%)
6 (50-60%) 7 (60-70%) 8 (70-80%) 9 (80-90%) 10 (90-100%)
Measured: Day 28, Day 56, Day 140
Secondary outcomes (4)
Subject Global Aesthetic Improvement Scale (SGAIS)
Subject Global Aesthetic Improvement Scale Assessment (SGAIS) How would you rate the change in appearance of your treated areas? Non-treated areas will be checked as "Not Treated" for you.
Rating Description
- Very Much Improved: Optimal cosmetic result
- Much Improved: Marked improvement in appearance form the initial condition, but not completely optimal
- Improved: Obvious improvement in appearance from initial condition
- No Change: The appearance is essentially the same as the original condition
- Worse: The appearance is worse than the original condition Scores (write a number to rate each treated area)
Left Facial Half Right Facial Half
Not Treated Not Treated
Measured: Day 28, Day 56, Day 140
Subject Satisfaction Questionnaire
Subject Satisfaction Questionnaire How would you rate your satisfaction of each treated area? Non-treated areas will be checked as "Not Treated" for you.
Rating Description 0 Not satisfied
- Somewhat satisfied
- Satisfied
- Very satisfied
- Extremely Satisfied Scores (write a number to rate each treated area)
Left Facial Half Right Facial Half
Measured: Day 140
Comfort level visual analog scale post-procedure by subjects
Visual Analog Scale - Left Facial Half Visual Analog Scale (Circle One)
1 2 3 4 5 6 7 8 9 10
Visual Analog Scale - Right Facial Half Visual Analog Scale (Circle One)
1 2 3 4 5 6 7 8 9 10
Measured: Baseline, Day 28, Day 56
Evaluation of side effects and adverse effects by investigators
Treating Investigator Evaluation of Side Effects Rating Description 0 NONE: Normal
- TRACE: Barely visible and localized
- MILD: Somewhat visible and diffuse
- MODERATE: Visible and diffuse
- SEVERE: Extremely visible and dense SCORES (write number under each treated area or check "Not Treated") Erythema Left Facial Half Right Facial Half
Edema Left Facial Half Right Facial Half
Hyperpigmentation Left Facial Half Right Facial Half
Hypopigmentation Left Facial Half Right Facial Half
Bruising Left Facial Half Right Facial Half
Ulcer Left Facial Half Right Facial Half
Measured: Baseline, Day 28, Day 56, Day 140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- subjects will be randomized to have either their right facial half or left facial half treated with the 1064nm picosecond laser with diffractive lens array. The contralateral facial half not randomized will be treated with the 755nm picosecond laser with diffractive lens array.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595525
- Sponsor's protocol ID
- Pico-Skin-Quality-2022-09
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Double-blinded, Randomized, Split-face Study Evaluating 1064nm Versus 755nm Picosecond Lasers With Diffractive Lens Array for Improvement of Skin Quality
- ClinicalTrials.gov ID
- NCT05595525
- Acronym / sponsor ID
- Pico-Skin-Quality-2022-09
- Conditions
- Skin Quality
- Keywords
- wrinkles, fine lines, sun spots, laxity, facial laxity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of a 1064nm picosecond laser (PicoWay; Candela; Marlborough, MA) with diffractive lens array and a picosecond 755nm laser (PicoSure®; Cynosure®; Westford, MA) with diffractive lens array in subjects for the improvement of facial skin quality. Secondary objectives of this clinical trial are to assess whether the 1064nm or 755nm picosecond laser is more efficacious in improving facial skin quality, safety of the procedure, comfortability of the procedure, and subject satisfaction.
Detailed description
subject will be randomized to have either their right facial half or left facial half treated with the 1064nm picosecond laser with diffractive lens array. The contralateral facial half not randomized will be treated with the 755nm picosecond laser with diffractive lens array. Subjects will receive three (3) treatments, four (4) weeks ± 7 days apart to each facial half.
For additional comfort, cold air cooling (Zimmer MedizinSystems, Irvine, CA) set on level 5 will be used throughout the treatment. After each treatment, subjects will be provided with CeraVe gentle facial cleanser (CeraVe; New York, NY) and CeraVe lotion (CeraVe; New York, NY) to be used twice daily for two weeks. Additionally, a mineral CeraVe sunscreen (CeraVe; New York, NY) will also be provided to subjects to be used every morning with reapplication every two (2) hours if going outside for the entirety of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- subjects will be randomized to have either their right facial half or left facial half treated with the 1064nm picosecond laser with diffractive lens array. The contralateral facial half not randomized will be treated with the 755nm picosecond laser with diffractive lens array.
| Arm | Type | Receives |
|---|---|---|
| Group A = right side face treated with 1064nm and left with 755nm | Experimental | Device: 1064NM pico Laser, Device: 755NM pico Lasersubject will have their right half of their face treated with the 1064nm picosecond laser with diffractive lens array. Then the contralateral, left half will be treated with the 755nm picosecond laser with diffractive lens array. Subjects will receive three (3) treatments, four (4) weeks ± 7 days apart to each facial half. |
| Group B = left side face treated with 1064nm and right with 755nm | Experimental | Device: 1064NM pico Laser, Device: 755NM pico Lasersubject will have their left half of their face treated with the 1064nm picosecond laser with diffractive lens array. Then the contralateral, right half will be treated with the 755nm picosecond laser with diffractive lens array. Subjects will receive three (3) treatments, four (4) weeks ± 7 days apart to each facial half. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adult males and females aged 18 to 65 years
- Fitzpatrick skin types I-VI
- Subjects in good general health based on investigator's judgment and medical history
- Must be willing to give and sign an informed consent form and photographic release form
- Willingness to have facial exams and digital photographs performed of the face
Key exclusion criteria (23 listed)
- Mesotherapy, dermal fillers, biostimulatory injectables, and/or fat grafting in the treatment area during the 12-month period before study treatment
- Energy-based device (i.e., radiofrequency device treatments, microfocused ultrasound device or other ultrasound-based device treatments, laser and light-based device treatments, microneedling) treatment in the treatment area in the last 6 months
- Surgery (i.e., face lift, eyebrow lift, neck lift or lower rhytidectomy, liposuction to the neck and/or submentum, etc.) during the 12-month period before study treatment
- Chemical peel or microdermabrasion of the face within 30 days prior to enrollment in the study
- Any investigational treatment for improvement of skin quality and/or photodamage of facial skin during the 12-month period before the study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1064NM pico LaserAlso: Candela 1064NM LaserThere have been small studies demonstrating the use of picosecond lasers for treatment of wrinkles and skin laxity; however, there have been no studies investigating the use of picosecond lasers for the overall improvement in skin quality. | Device | Group A = right side face treated with 1064nm and left with 755nm, Group B = left side face treated with 1064nm and right with 755nm |
| 755NM pico LaserAlso: Cynosure 755NM LaserThere have been small studies demonstrating the use of picosecond lasers for treatment of wrinkles and skin laxity; however, there have been no studies investigating the use of picosecond lasers for the overall improvement in skin quality. | Device | Group A = right side face treated with 1064nm and left with 755nm, Group B = left side face treated with 1064nm and right with 755nm |
Primary outcome
Scientific Assessment Scale of Skin Quality (SASSQ) to assess change
Time frame: Screening, Baseline, Day 28, Day 56, Day 140
Scientific Assessment Scale of Skin Quality (SASSQ) (circle one) Elasticity 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Wrinkles 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Skin Surface Roughness 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Lentigines/ Pigmentation 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Erythema 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Pore Size 0- Fine 1- Small 2- Moderate 3- Large 4- Very Large
Physician Global Aesthetic Improvement Scale (PGAIS) by blinded investigator to assess change
Time frame: Day 28, Day 56, Day 140
Blinded Physician Global Aesthetic Improvement Scale Assessment (PGAIS) Rating Description 1. Very Much Improved: Optimal cosmetic result in this subject. 2. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject. 3. Improved: Obvious improvement in appearance from initial condition, but a re- treatment is indicated. 4. No Change: The appearance is essentially the same as the original condition. 5. Worse: The appearance is worse than the original condition. Scores (write a number under each treated area or check "Not Treated") Left Facial Half Right Facial Half Not Treated Not Treated
Percent improvement of skin quality by blinded investigator to assess change
Time frame: Day 28, Day 56, Day 140
Blinded Investigator Percent Improvement Evaluation - Left Facial Half Degree of improvement from clinical evaluation, compare to baseline, using a 1-10 scale. 1 (0-10%) 2 (10-20%) 3 (20-30%) 4(30-40%) 5 (40-50%) 6 (50-60%) 7 (60-70%) 8 (70-80%) 9 (80-90%) 10 (90-100%) Blinded Investigator Percent Improvement Evaluation - Right Facial Half Degree of improvement from clinical evaluation, compare to baseline, using a 1-10 scale. 1 (0-10%) 2 (10-20%) 3 (20-30%) 4(30-40%) 5 (40-50%) 6 (50-60%) 7 (60-70%) 8 (70-80%) 9 (80-90%) 10 (90-100%)
4 secondary outcomes
Subject Global Aesthetic Improvement Scale (SGAIS)
Time frame: Day 28, Day 56, Day 140
Subject Satisfaction Questionnaire
Time frame: Day 140
Comfort level visual analog scale post-procedure by subjects
Time frame: Baseline, Day 28, Day 56
Evaluation of side effects and adverse effects by investigators
Time frame: Baseline, Day 28, Day 56, Day 140
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing 1064NM pico Laser and 755NM pico Laser in people with Skin Quality, run by Goldman, Butterwick, Fitzpatrick and Groff.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Pacheco (8586571004, apacheco@clderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scientific Assessment Scale of Skin Quality (SASSQ) to assess change (time frame: Screening, Baseline, Day 28, Day 56, Day 140). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.